The global enzyme-linked immunosorbent assay (ELISA) market is expected to grow at a CAGR of 5.76% to reach a market value of USD YY million by 2027 from an initial value of 1615.10 in 2019.
Enzyme-Linked Immunosorbent Assay (ELISA) is a plate-based assay technique designed for detecting and quantifying substances such as proteins, peptides, antibodies, and hormones.The ELISA is used as a diagnostic tool in medicine, plant pathology, and biotechnology, as well as quality control, check in various industries. ELISA is a biochemical reaction in which an antigen from the sample is attached to a surface and then complexed with an antibody that is linked to an enzyme.
The reaction produces a detectable signal, most commonly a color change in the substrate which is highly specific to the antibody-antigen interaction. The conventional diagnostic applications of ELISA are pregnancy tests, HIV infection, and measurement of soluble proteins, cytokines, and others.
Several companies have adopted collaborations and use new product launches to help them to stand out as strong competitors in the market and also expand its sales in the global ELISA market. January 2019, New ELISA blood test, sclera-smart, from Gemelli Biotech measures levels of anti-vinculin, recently found to be elevated in patients with scleroderma and associated with gastrointestinal complications. It suggests a link between scleroderma and the gut microbiome, a finding that could open the door to discoveries of new microbiome-related therapeutic and diagnostic tools for scleroderma. October 2018, the U.S. Food and Drug Administration (FDA) approved marketing of the PicoAMH Elisa diagnostic test (determine women’s menopausal status) to Ansh Labs, a developer, and manufacturer of immunoassay reagent test kits used to advance target discovery, therapeutic development, biomedical research, and clinical diagnostics.The company will market its Anti-Müllerian (AMH) assay kit, picoAMH, under the trademark MenoCheck. May 2017, ALPCO launched new ELISA products, gastrointestinal and inflammatory bowel disease (IBD) assays. They are the Zonulin Stool ELISA and Zonulin Serum ELISA and aid in the study of gut permeability and celiac disease.
Market Dynamics
Drivers
- Rising Incidence of chronic diseases
- Growing awareness and supportive government efforts
Restraints
- Limitations associated with ELISA leads to alternatives
- Stringent regulatory framework
Growing awareness and supportive government efforts are driving the growth of the enzyme linked immunosorbent assay treatment market globally.
Several healthcare experts are concentrating on the creation and adoption of effective diagnostic and treatment solutions to check the level of prevalence. Early diagnosis raises the success rate of treatments, thereby reducing the death rates caused due to enzyme linked immunosorbent assay. In October 2019, two diagnostic kits were developed by Indian Council of Agricultural Research (ICAR) - Indian Veterinary Research Institute (IVRI) under the ‘Make in India’ initiative, namely the Bluetongue sandwich ELISA (sELISA) and the Japanese Encephalitis lgM ELISA kit for the control of Swine and Detection of Antigen. This indigenous technology will not just help save foreign exchange as the newly developed kits cost ten times lesser than the imported ones but also has the potential to earn foreign exchange. On 31st July 2018, the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) launched a trial version of a new ELISA: A kit, simpler and faster to perform, which is one of the basic tests needed for laboratory confirmation of yellow fever.
Competitive ELISA
The competitive ELISA market is valued at USD 195.41 Mn in 2018 and is estimated to grow at a CAGR of 4.67% over the forecast period to reach USD XX Mn by 2027.
The collective revenue of the competitive ELISA segment is expected to generate US$ 1,918.0 Million during 2020-2027. The competitive ELISA segment holds 12.10% of the market share in 2018, and is expected to be 11.14% by 2026, for the global enzyme linked immunosorbent assay (ELISA) market. Competitive ELISAs are commonly used for small molecules, when the protein of interest is too small to efficiently sandwich with two antibodies. Similar to a sandwich ELISA, a capture antibody is coated on a microplate. Instead of using a conjugated detection antibody, a conjugated antigen is used to complete binding with the antigen present in the sample. The more antigen present in the sample, the less conjugated antigen will bind to the capture antibody. Substrate is added and the signal produced is inversely proportional to the amount of protein present in the sample.
Compared with the three ELISA types above, competitive ELISA is relatively complex because it involves the use of inhibitor antigen, so competitive ELISA is also known as inhibition ELISA. The other three formats, direct, indirect, and sandwich, can be adapted to the competitive format. In competitive ELISA, the inhibitor antigen and the antigen of interest compete for binding to the primary antibody. Competitive ELISA generally uses a labeled antibody for detection, but sometimes it uses labeled antigen instead of a labeled antibody.
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